系统性审查后续治疗的时间作为高级固体瘤的候选代用终点
Paul Agapow1, Rob Mulla1, Natasha Markuzon2
1Oncology R&D ML & AI, AstraZeneca, City House, 130 Hills Rd, Cambridge, Cambridgeshire, CB2 1RE, UK.
Future oncology (London, England)
|August 17, 2023
概括
在先进的固体瘤中,到第一个后续治疗或死亡的时间 (TFST) 与无进展生存率 (PFS) 密切相关. 然而,TFST与整体存活率 (OS) 的相关性较弱,这表明它是PFS更好的替代品.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 随后治疗的时间 (TST) 是瘤学临床试验的一个新兴终点.
- 在评估抗癌药物疗效时,TST可以补充无进展生存率 (PFS) 和总生存率 (OS).
- 作为PFS和OS的替代品,TST的实用性需要进行系统的评估.
研究的目的:
- 系统地审查TST与PFS和OS之间的相关性.
- 评估TST作为高级固体瘤中替代终点的潜力.
主要方法:
- 发表的2/3期研究的系统审查.
- 试验级的相关性分析比较TST (包括到第一个后续治疗或死亡的时间 - TFST) 与PFS (研究者和中央审查) 和OS.
主要成果:
- 包括21项研究,对TST有不同的定义.
- 到第一次后续治疗或死亡的时间 (TFST) 与PFS有很强的相关性 (R2=0.86-0.91).
- TFST显示与整体存活时间 (OS) 有中低相关性 (R2=0.02-0.64).
结论:
- 时间到第一次后续治疗或死亡 (TFST) 是无进展生存 (PFS) 的强有力的替代品.
- 在先进的固体瘤中,TFST不是整体存活 (OS) 的可靠替代品.
- 需要对TST的标准化定义,以便在各个研究中进行一致的解释.
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